Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorRush University Medical Center
About this trial
This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients > 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography
Native papilla
Disqualifiers
Patients with altered pancreaticobiliary anatomy
Pregnancy
Patients with percutaneous transhepatic biliary drainage
Prior history of ERCP
Trial design
Design model
Parallel
Treatments tested in this trial
Exalt Model D
DeviceExalt Model D single-use duodenoscope will be used in ERCP
Reusable
DeviceStandard reusable duodenoscope will be used in ERCP
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Exalt Model DExperimental treatment 1 intervention
Group B: Standard ReusableActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of attempts required to achieve successful cannulation of the desired duct
Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.
Time frame
From the time of the ERCP to 7 days post-ERCP per standard of careSecondary outcomes
1
Crossover single to reusable
The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
Time frame
From the start of the ERCP to the end of procedure2
Use of advanced cannulation techniques
The utilization of advanced cannulation techniques in ERCP procedure
Time frame
From the start of the ERCP to the end of procedure3
Performance on ERCP maneuvers
Subjective ratings on 14 ERCP maneuvers. ("not preferred/neutral/preferred" relative to the reusable duodenoscope endoscopist usually uses in clinical practice), 23 device performance characteristics. (Likert scale of 1 \[not preferred\] to 5 \[comparable with reusable duodenoscope\])
Time frame
From the start of the ERCP to the end of procedure4
Adverse events
Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
Time frame
From the completion of the ERCP to 7 days post-ERCP per standard of careSponsors and contacts
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Source ClinicalTrials.gov